Tag: Food and Drug Administration

Translational research and preclinical data

Donald Trump versus the FDA: Is the standard of evidence for drug approval actually too low rather than too high?

All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?

/ February 6, 2017
A_cosmic_couple duty calls

Corrigendum. The Week in SBM for 01.29.2017

Not every article and study that pops up my feeds in the world of pseudo-medicine is worthy of a complete blog post. But they need to be noticed and commented upon: FDA confirms elevated levels of belladonna in certain homeopathic teething products. Homeopaths prove water not toxic to fish. Lots of acupuncture recommendations, little good data. Everything is CAM. And more! Duty...

/ January 29, 2017
Food and Drug Administration building.

Donald Trump and Peter Thiel vs. the FDA: Be afraid. Be very afraid.

Donald Trump's three most likely picks for FDA Commissioner all favor loosening drug approval standards. Two are cronies of Peter Thiel, of which one believes that the FDA shouldn't require evidence of efficacy, only safety, and the other believes that a "Yelp for drugs" would do a better job than the FDA. The third candidate is a bona fide, honest-to-goodness pharma shill....

/ January 16, 2017
homeopathy-air-guitar

FTC Homeopathy Win

I love to see a regulatory agency actually do its job. Especially within medicine, where it is most important, the lack of political will seems to get in the way of properly regulating health care products and services in the way that most consumers assume they are regulated. Homeopathy is perhaps the best example. Homeopathy is pure unadulterated pseudoscience and witchcraft. There...

/ November 16, 2016
When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

Medical science policy in the U.S. under Donald Trump

The election of Donald Trump was unexpected. Given Trump's history of antivaccine beliefs and conspiracy theories, coupled with a fervor for deregulation (a fervor shared by the Republican Congress), it is reasonable to fear what will happen to medical science policy during the next four years.

/ November 14, 2016
homeopathic-products

An Update on FDA Concerns Over Homeopathic Teething Products

Steven Novella recently wrote a post discussing an FDA warning against the use of homeopathic teething products over safety concerns related to the possibility of toxic amounts of belladonna. He goes into the hypocrisy of the FDA regulation of homeopathic products, a topic covered numerous times here on Science-Based Medicine, as well as the misleading initial response from Hyland’s, producers of the...

/ October 21, 2016
all-seeing-eye

Stem Cell Tourism for Eye Disease: No Passport Required

Stem cell clinics outside the United States, and outside the jurisdiction of the U.S. regulations, have flourished and the pursuit of treatment at these centers has been called “stem cell tourism.” Seekers of unproven stem cell therapies no longer need to look outside the U.S. Paul Knoepfler, a stem cell researcher and leading advocate for the responsible use of stem cell technology,...

/ October 16, 2016
Food and Drug Administration building.

FDA Warns About Homeopathic Teething Products

The FDA recently put out a consumer warning about homeopathic teething gels and pills. The warning states: The FDA recommends that consumers stop using these products and dispose of any in their possession. The warning is not because all homeopathic products are inherently useless. As we have discussed here often, the basic principles of homeopathy are pure pseudoscience. The practice of diluting...

/ October 5, 2016
herbs-nd1

FDA efforts to improve compounded drug safety upsets naturopaths

Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances. According to the American Association of Naturopathic Physicians (AANP) these nutritional, herbal and homeopathic remedies are compounded to meet unique patient...

/ July 7, 2016
SnakeOilSalesmanWagon

Forget stem cell tourism: Stem cell clinics in the US are plentiful

It's generally thought that quack stem cell clinics are primarily a problem overseas because the FDA would. never allow them on US soil. As a new survey shows, that assumption couldn't be more wrong.

/ July 4, 2016